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ObsEva's (OBSV) Yselty Gets EU Nod to Treat Uterine Fibroids

02:46pm, Friday, 17'th Jun 2022 Zacks Investment Research
ObsEva's (OBSV) Yselty receives its first marketing approval in the European Union for the treatment of uterine fibroids in adult women. Shares were up 11% in pre-market trading following the news.

Rhythm Pharma (RYTM) Down on Mixed Imcivree Regulatory Updates

01:41pm, Friday, 17'th Jun 2022 Zacks Investment Research
The FDA approves label expansion of Rhythm Pharma's (RYTM) Imcivree to include Bardet-Biedl Syndrome patients. However, the FDA provides CRL for label expansion of the drug in Alstrom syndrome.

Clovis (CLVS) Up 19.4% on Upbeat Data From Solid Tumor Study

08:20pm, Thursday, 16'th Jun 2022 Zacks Investment Research
Clovis Oncology (CLVS) reports favorable data from a study, which supports the potential clinical utility of FAP-2286, its targeted radiotherapy candidate, as a treatment for advanced solid tumors.

Pfizer (PFE) COVID Pill Ineffective in Standard Risk Patients

07:22pm, Wednesday, 15'th Jun 2022 Zacks Investment Research
Pfizer (PFE) stops enrolling patients in a phase II/III study evaluating its COVID pill in standard-risk population after new data from this study showed that it is not all statistically significant.

Ionis' (IONS) Angelman Syndrome Drug Gets FDA's Orphan Tag

05:00pm, Tuesday, 14'th Jun 2022 Zacks Investment Research
The FDA grants orphan drug and rare pediatric disease designations to Ionis' (IONS) ION582 for treating Angelman syndrome. These designations will help incentivize development of the candidate.

Merck (MRK) Keytruda Adjuvant Lung Cancer sBLA Accepted by FDA

02:33pm, Tuesday, 14'th Jun 2022 Zacks Investment Research
The FDA is expected to give its decision on Merck's (MRK) Keytruda sBLA for adjuvant stage IB-IIIA NSCLC, following complete surgical resection, on Jan 29, 2023.

ImmunoGen (IMGN) Enters New Collaboration to Boost ADC Pipeline

02:02pm, Tuesday, 14'th Jun 2022 Zacks Investment Research
ImmunoGen (IMGN) inks a collaboration deal with privately-held Oxford BioTherapeutics to develop novel antibody-drug conjugates by complementing each other's proprietary technologies.

FDA Committee Endorses bluebird's (BLUE) Thalassemia Therapy

05:27pm, Monday, 13'th Jun 2022 Zacks Investment Research
An FDA advisory committee favors approval for bluebird bio's (BLUE) beti-cel to treat transfusion-dependent thalassemia. A final decision by the regulatory body is expected on Aug 19, 2022.

Cogent (COGT) Surges on Robust Data from Mastocytosis Study

02:53pm, Monday, 13'th Jun 2022 Zacks Investment Research
Cogent's (COGT) bezuclastinib achieves robust effectiveness in patients with advanced systemic mastocytosis with a favorable safety and tolerability profile. Stock surges more than 58% on Jun 10.

GSK's RSV Vaccine Candidate Offers Robust Protection in Elderly

01:41pm, Monday, 13'th Jun 2022 Zacks Investment Research
GSK's RSV vaccine candidate for adults aged 60 years or above achieves statistically significant and clinically meaningful efficacy in a phase III study. Regulatory submissions are likely in the secon

FDA Committee Recommends bluebird's (BLUE) CALD Therapy

07:30pm, Friday, 10'th Jun 2022 Zacks Investment Research
An FDA advisory committee supports approving bluebird bio's (BLUE) eli-cel for treating cerebral adrenoleukodystrophy. NASDAQ halts trading BLUE's common stock on Jun 9 and 10.

Top Penny Stocks To Buy? 4 Biotech Stocks To Watch Now

11:20pm, Thursday, 09'th Jun 2022 PennyStocks
Biotech penny stocks to watch in June. The post Top Penny Stocks To Buy? 4 Biotech Stocks To Watch Now appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
Biotech penny stocks to watch in June. The post Top Penny Stocks To Buy?

Vertex (VRTX) Kidney Drug Gets FDA Breakthrough Designation

12:25pm, Thursday, 09'th Jun 2022 Zacks Investment Research
Vertex (VRTX) inaxaplin is being evaluated in a single-phase II/III pivotal study in patients with AMKD with two APOL1 mutations and proteinuric kidney disease.

bluebird (BLUE) Up as FDA Nod Likely for Thalassemia Therapy

05:21pm, Wednesday, 08'th Jun 2022 Zacks Investment Research
Based on briefing documents issued by the FDA, a positive regulatory approval is expected on bluebird bio's (BLUE) gene-therapy for treating thalassemia.
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